Traditional Chinese medicine (TCM) safety assessment is an important content of post-marketing Chinese herbal medicine assessment and the primary question. It includes safety monitoring and safety evaluation. China has established the elementary system for the TCM safety monitoring, but did few things on safety evaluation. People have knew that the methods of pharmacoepidemiology have good practicability on drug safety assessment in recent years. This article analyzed three methods of pharmacoepidemiology used in post-marketing Chinese herbal medicine safety assessment. There are three examples that may give some suggestions to fellow doctors working for safety monitoring and evaluation of TCM.
Drug-Related Side Effects and Adverse Reactions ; Humans ; Medicine, Chinese Traditional ; adverse effects ; Pharmacoepidemiology ; methods ; Product Surveillance, Postmarketing ; methods ; Risk Assessment

Anemia is one of the most common complications of rheumatoid arthritis （RA）. It is an important factor affecting the quality of life of patients and disease prognosis in addition to joint dysfunction. The pathogenesis of RA with anemia in western medicine is complex and diverse， and it is difficult to give consideration to medication. Traditional Chinese medicine （TCM） has certain therapeutic advantages because it pays attention to overall regulation and syndrome differentiation. In recent years， with the in-depth exploration of the pathogenesis of RA in modern medicine and the continuous improvement of the idea of diagnosis and treatment combined with disease and syndrome in TCM， the connotation of TCM pathogenesis of RA has gradually broken through the traditional theoretical framework of "arthralgia syndrome"， and TCM etiology research of toxin in RA and its complications has received increasing attention. By tracing and sorting out the theory of "toxin caused arthralgia"， combing with the research results of the pathological mechanism of modern medicine， this thesis expounds the importance of toxins in the pathogenic factors of RA in TCM. On this basis， it is further proposed that "deficiency caused by toxic heat" is the core pathogenesis of RA with anemia. Deficiency of healthy Qi， the six exogenous factors， the seven emotional factors， and improper diet can lead to the formation of toxic heat， and damage to the joint structure and viscera， resulting in blood deficiency. To treat RA with anemia， the syndrome differentiation by stages is conducted based on the principle of detoxification and dredging collaterals， and the mechanism of self-made prescription Ersi decoction on RA complicated with anemia is explored based on previous research， to enrich the theoretical basis for the treatment of RA from toxic heat and provide new ideas for TCM differentiation and treatment of RA with anemia and other complications.

Objective To establish female and male bovine collagen-induced arthritis(CIA)models and compare the effects of gender differences on joint and extra-articular manifestations of the CIA model.Methods The CIA model was induced by injection of bovine type Ⅱ collagen and Freund's complete adjuvant into female and male SD rats.The general condition,arthritis index,foot swelling,serum proinflammatory factors and plasminogen activator inhibitor levels,spleen index,knee and ankle joint pathologies,right rear paw bone destruction,and pulmonary interstitial lesions were evaluated.Results The arthritis index of female CIA rats was significantly higher than that of male CIA rats on day 21 after initial immunization(P＜0.05),but no significant difference was found in the degree of foot swelling between the two groups at any time point(P＞0.05).Serum tumor necrosis factor α,interleukin-1β,and the spleen index of female CIA rats were significantly higher than those of male CIA rats(P＜0.05,P＜0.001).No significant difference was found in plasminogen activator inhibitor levels(P＞0.05).The scores of inflammatory cell infiltration and synovial hyperplasia in the knee and ankle pathologies of female CIA rats were significantly higher than those of male CIA rats(P＜0.05),and cartilage damage of the knee joint and bone damage of the right rear paw of female CIA rats were significantly higher than that of male rats(P＜0.05).Both male and female CIA rats showed pulmonary interstitial inflammatory cell infiltration and mild fibrosis,but the pulmonary interstitial lesions in females were more severe than those in males.Conclusions Female and male CIA models established in SD rats have arthritis and pulmonary interstitial lesions,but the lesion degree in female CIA rats is more serious.When using CIA models for RA-related research,attention should be focused on the effect of gender differences.

Background: Dietary fiber is strongly recommended as the basic treatment for functional constipation according to global guidelines. However, a complete evaluation standard for the laxative functional food remains to be improved in China. Aims: To evaluate the efficacy and safety of the laxative function of a compound fructose-oligosaccharide fiber granule, so as to provide evidence-based medical basis for the evaluation of laxative functional food. Methods: In a randomized, double-blind, parallel and controlled trial with placebo as control, 120 subjects with functional constipation were enrolled in 2 clinical research centers in Beijing, and randomly divided into experimental group and control group (60 cases in each group). Subjects in experimental group were given a compound fructose-oligosaccharide fiber granule dissolved in 50 mL water orally, 1 bag (9 g) per day for 2 weeks; while those in control group were given a placebo granule with the same appearance, specification and dosage as the experimental group. The bowel movement frequency per week, defecation status and stool consistency were recorded before and after the test, and the safety tests were completed. Results: After 2 weeks of treatment, the bowel movement frequency in experimental group increased by (1.63±1.57) times per week, the stool consistency assessed by Bristol stool form scale and the difficulty in defecation were also improved as compared with the baseline (all P<0.05). Furthermore, improvements in experimental group were superior to those in control group (all P<0.05). No allergic and other adverse events were reported during the test, and there were no significant changes in blood, urine, stool routine and blood biochemical indices before and after the test. Conclusions: The compound fructose-oligosaccharide fiber granule tested in this study is proved to have laxative effect and is safety for functional constipation. The testing program is scientific and of feasibility, and may provide a methodology basis for human oral administration trials of laxative functional food.